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Trial record 1 of 1 for:    NCT03218787
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XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

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ClinicalTrials.gov Identifier: NCT03218787
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : November 5, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Lesions
Interventions Device: XIENCE
Drug: DAPT
Enrollment 2047
Recruitment Details A total of 2047 subjects were registered in XIENCE 90 from 101 sites in the US between 19 July, 2017 and 09 August, 2019. The last patient visit was on 04 September, 2020.
Pre-assignment Details  
Arm/Group Title XIENCE
Hide Arm/Group Description

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Period Title: Overall Study
Started 2047
Completed 1841
Not Completed 206
Reason Not Completed
Lost to Follow-up             12
Withdrawal by Subject             72
Physician Decision             11
Death             111
Arm/Group Title XIENCE
Hide Arm/Group Description

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Baseline Participants 2047
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2047 participants
75.10  (9.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2047 participants
Female
726
  35.5%
Male
1321
  64.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2047 participants
American Indian or Alaska Native
11
   0.5%
Asian
45
   2.2%
Black or African American
125
   6.1%
Hispanic or Latino
57
   2.8%
Native Hawaiian or Pacific Islander
6
   0.3%
White
1804
  88.1%
Did not wish to disclose
55
   2.7%
Not available
1
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2047 participants
2047
 100.0%
Chronic anticoagulant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2047 participants
836
  40.8%
1.Primary Outcome
Title Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI)(Modified Academic Research Consortium [ARC]), by Propensity Score Quintiles
Hide Description

All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease should be classified as cardiac.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block, development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI
  • Spontaneous MI: CK-MB > URL or Troponin > URL with baseline value < UR

The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome & the baseline demographic, clinical and procedural covariates as the predictors

Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Number
Unit of Measure: Percentage of participants
Adjusted Overall Rate Number Analyzed 1672 participants
5.4
Q1 Number Analyzed 104 participants
6.7
Q2 Number Analyzed 225 participants
4.0
Q3 Number Analyzed 361 participants
3.6
Q4 Number Analyzed 446 participants
5.8
Q5 Number Analyzed 536 participants
6.9
2.Secondary Outcome
Title Percentage of Participants With Major Bleeding Rate by Bleeding Academic Research Consortium (BARC) Type 2-5, by Propensity Score Quintiles
Hide Description
  • Type 2: Any overt, actionable sign of hemorrhage
  • Type 3a: Overt bleeding plus Hb drop of 3 to < 5g/dL;Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL;Cardiac tamponade;Bleeding requiring surgical intervention for control;Bleeding requiring IV vasoactive agents
  • Type 3c: ICH; Subcategories confirmed by autopsy/imaging/lumbar puncture;Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48h;Reoperation after closure of sternotomy for the purpose of controlling bleeding;Transfusion of ≥ 5 U whole blood or packed RBC within 48h;Chest tube output ≥ 2L within 24h
  • Type 5: Fatal bleeding

The propensity score for each individual was calculated using a logistic regression model that included the study group as the outcome & the baseline demographic, clinical and procedural covariates as the predictors.

Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1629
Measure Type: Number
Unit of Measure: Percentage of participants
Adjusted Overall Rate Number Analyzed 1629 participants
5.1
Q1 Number Analyzed 102 participants
3.9
Q2 Number Analyzed 221 participants
2.7
Q3 Number Analyzed 353 participants
5.4
Q4 Number Analyzed 435 participants
6.0
Q5 Number Analyzed 518 participants
7.7
3.Secondary Outcome
Title Number of Participants With Stent Thrombosis (ARC Definite/Probable)
Hide Description

Definite stent thrombosis:

Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

Probable stent thrombosis:

Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days
  • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1635
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.2%
4.Secondary Outcome
Title Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Hide Description

All Death:

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

Vascular death:

Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

Non-cardiovascular death:

Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
54
   3.2%
5.Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Hide Description

All Myocardial Infarction (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
48
   2.9%
6.Secondary Outcome
Title Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Hide Description

Cardiac death:

Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

MI (Modified ARC):

Patients present any of the following clinical or imaging evidence of ischemia:

  • Clinical symptoms of ischemia;
  • ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves;
  • Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality)

AND confirmed with elevated cardiac biomarkers per ARC criteria:

  • Periprocedural MI:

    • Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL
    • Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL
  • Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
67
   4.0%
7.Secondary Outcome
Title Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Hide Description

An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.

  • Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.
  • Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage.
  • Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic.
  • Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1624
Measure Type: Count of Participants
Unit of Measure: Participants
21
   1.3%
8.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Hide Description

Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography.

Clinically Indicated [CI] Revascularization:

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test
  • A TLR/TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
16
   1.0%
9.Secondary Outcome
Title Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Hide Description

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

  • A positive history of recurrent angina pectoris, presumably related to the target vessel;
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
  • Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);
  • A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
26
   1.6%
10.Secondary Outcome
Title Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Hide Description TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
66
   3.9%
11.Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF, Composite of Cardiac Death, TV-MI and CI-TVR)
Hide Description TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1672
Measure Type: Count of Participants
Unit of Measure: Participants
70
   4.2%
12.Secondary Outcome
Title Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5
Hide Description

Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:

  • Type 3a: Overt bleeding plus Hemoglobin(Hb) drop of 3 to < 5 g/dL; Any transfusion with overt bleeding
  • Type 3b: Overt bleeding plus Hb drop ≥ 5 g/dL; Cardiac tamponade; Bleeding requiring surgical intervention for control; Bleeding requiring IV vasoactive agents
  • Type 3c: Intracranial hemorrhage;Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed compromising vision
  • Type 4: CABG-related bleeding: Perioperative intracranial bleeding within 48 h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of ≥ 5 U whole blood or packed red blood cells within a 48-h period; Chest tube output ≥ 2L within a 24-h period
  • Type 5: Fatal bleeding
  • Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious
  • Type 5b: Definite fatal bleeding;overt bleeding or autopsy or imaging confirmation
Time Frame From 3 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title XIENCE
Hide Arm/Group Description:

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Overall Number of Participants Analyzed 1629
Measure Type: Count of Participants
Unit of Measure: Participants
41
   2.5%
Time Frame 1 Year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XIENCE
Hide Arm/Group Description

Subjects will receive XIENCE family stent systems and 3-month DAPT

XIENCE: Subjects will receive XIENCE family stents and if a subject was DAPT compliant and event free, then took 3 month DAPT, following with aspirin mono-therapy until 12 month

DAPT: 3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.

Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

All-Cause Mortality
XIENCE
Affected / at Risk (%)
Total   115/2047 (5.62%)    
Hide Serious Adverse Events
XIENCE
Affected / at Risk (%) # Events
Total   898/2047 (43.87%)    
Blood and lymphatic system disorders   
Anaemia  1  60/2047 (2.93%)  62
Anaemia macrocytic  1  1/2047 (0.05%)  1
Bone marrow failure  1  1/2047 (0.05%)  1
Coagulopathy  1  2/2047 (0.10%)  2
Haemorrhagic anaemia  1  14/2047 (0.68%)  15
Iron deficiency anaemia  1  7/2047 (0.34%)  7
Leukocytosis  1  1/2047 (0.05%)  1
Normochromic normocytic anaemia  1  1/2047 (0.05%)  1
Splenic infarction  1  1/2047 (0.05%)  1
Thrombocytopenia  1  1/2047 (0.05%)  1
Cardiac disorders   
Acute left ventricular failure  1  3/2047 (0.15%)  3
Acute myocardial infarction  1  4/2047 (0.20%)  4
Angina pectoris  1  146/2047 (7.13%)  180
Angina unstable  1  5/2047 (0.24%)  5
Aortic valve incompetence  1  1/2047 (0.05%)  1
Aortic valve stenosis  1  4/2047 (0.20%)  4
Arrhythmia  1  3/2047 (0.15%)  3
Arteriosclerosis coronary artery  1  3/2047 (0.15%)  3
Atrial fibrillation  1  101/2047 (4.93%)  116
Atrial flutter  1  15/2047 (0.73%)  16
Atrial tachycardia  1  2/2047 (0.10%)  2
Atrioventricular block  1  1/2047 (0.05%)  1
Atrioventricular block complete  1  5/2047 (0.24%)  5
Atrioventricular block second degree  1  2/2047 (0.10%)  2
Bradyarrhythmia  1  1/2047 (0.05%)  1
Bradycardia  1  20/2047 (0.98%)  21
Bundle branch block left  1  1/2047 (0.05%)  1
Cardiac amyloidosis  1  1/2047 (0.05%)  1
Cardiac arrest  1  16/2047 (0.78%)  16
Cardiac disorder  1  2/2047 (0.10%)  2
Cardiac failure  1  14/2047 (0.68%)  15
Cardiac failure acute  1  11/2047 (0.54%)  12
Cardiac failure chronic  1  1/2047 (0.05%)  1
Cardiac failure congestive  1  87/2047 (4.25%)  109
Cardiac perforation  1  1/2047 (0.05%)  1
Cardiac tamponade  1  2/2047 (0.10%)  2
Cardio-respiratory arrest  1  5/2047 (0.24%)  5
Cardiogenic shock  1  8/2047 (0.39%)  9
Cardiomyopathy  1  3/2047 (0.15%)  3
Coronary artery disease  1  15/2047 (0.73%)  15
Coronary artery dissection  1  2/2047 (0.10%)  2
Coronary artery occlusion  1  2/2047 (0.10%)  2
Coronary artery stenosis  1  2/2047 (0.10%)  2
Ischaemic cardiomyopathy  1  3/2047 (0.15%)  3
Left ventricular hypertrophy  1  1/2047 (0.05%)  1
Mitral valve disease  1  1/2047 (0.05%)  1
Mitral valve incompetence  1  6/2047 (0.29%)  6
Mitral valve stenosis  1  3/2047 (0.15%)  3
Myocardial infarction  1  56/2047 (2.74%)  65
Myocardial ischaemia  1  1/2047 (0.05%)  1
Nodal rhythm  1  1/2047 (0.05%)  1
Palpitations  1  4/2047 (0.20%)  4
Pericardial effusion  1  6/2047 (0.29%)  6
Pericarditis  1  2/2047 (0.10%)  2
Right ventricular failure  1  1/2047 (0.05%)  1
Sick sinus syndrome  1  6/2047 (0.29%)  6
Sinus arrest  1  1/2047 (0.05%)  1
Sinus arrhythmia  1  1/2047 (0.05%)  1
Sinus bradycardia  1  1/2047 (0.05%)  1
Supraventricular tachycardia  1  6/2047 (0.29%)  6
Tachycardia  1  3/2047 (0.15%)  3
Tricuspid valve incompetence  1  2/2047 (0.10%)  2
Ventricular arrhythmia  1  1/2047 (0.05%)  1
Ventricular fibrillation  1  2/2047 (0.10%)  3
Ventricular tachycardia  1  12/2047 (0.59%)  12
Congenital, familial and genetic disorders   
Gastrointestinal arteriovenous malformation  1  1/2047 (0.05%)  1
Haemorrhagic arteriovenous malformation  1  1/2047 (0.05%)  1
Endocrine disorders   
Hyperparathyroidism  1  1/2047 (0.05%)  1
Eye disorders   
Age-related macular degeneration  1  1/2047 (0.05%)  1
Cataract  1  3/2047 (0.15%)  4
Conjunctival haemorrhage  1  1/2047 (0.05%)  1
Eye haemorrhage  1  1/2047 (0.05%)  1
Glaucoma  1  1/2047 (0.05%)  1
Macular fibrosis  1  1/2047 (0.05%)  1
Retinal haemorrhage  1  1/2047 (0.05%)  1
Retinoschisis  1  1/2047 (0.05%)  1
Vision blurred  1  1/2047 (0.05%)  1
Visual impairment  1  1/2047 (0.05%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  1/2047 (0.05%)  1
Abdominal hernia  1  1/2047 (0.05%)  1
Abdominal pain  1  4/2047 (0.20%)  4
Abdominal pain upper  1  1/2047 (0.05%)  1
Abdominal wall haematoma  1  1/2047 (0.05%)  1
Ascites  1  1/2047 (0.05%)  1
Barrett's oesophagus  1  1/2047 (0.05%)  1
Colitis  1  2/2047 (0.10%)  2
Colonic polyp  1  4/2047 (0.20%)  4
Colonic pseudo-obstruction  1  1/2047 (0.05%)  1
Constipation  1  2/2047 (0.10%)  2
Dental caries  1  1/2047 (0.05%)  1
Diabetic gastroparesis  1  1/2047 (0.05%)  1
Diarrhoea  1  3/2047 (0.15%)  3
Diarrhoea haemorrhagic  1  2/2047 (0.10%)  2
Diverticulum  1  2/2047 (0.10%)  2
Dyspepsia  1  1/2047 (0.05%)  1
Dysphagia  1  1/2047 (0.05%)  1
Enterocolitis  1  1/2047 (0.05%)  1
Faeces discoloured  1  2/2047 (0.10%)  2
Gastric ulcer  1  2/2047 (0.10%)  2
Gastritis  1  1/2047 (0.05%)  1
Gastrointestinal angiodysplasia haemorrhagic  1  1/2047 (0.05%)  1
Gastrointestinal haemorrhage  1  43/2047 (2.10%)  46
Gastrointestinal motility disorder  1  1/2047 (0.05%)  1
Gastrointestinal ulcer haemorrhage  1  2/2047 (0.10%)  2
Gastrooesophageal reflux disease  1  3/2047 (0.15%)  3
Gingival bleeding  1  1/2047 (0.05%)  1
Haematemesis  1  7/2047 (0.34%)  7
Haematochezia  1  9/2047 (0.44%)  9
Haemorrhoidal haemorrhage  1  2/2047 (0.10%)  2
Haemorrhoids  1  1/2047 (0.05%)  1
Hiatus hernia  1  2/2047 (0.10%)  2
Ileus  1  3/2047 (0.15%)  3
Impaired gastric emptying  1  3/2047 (0.15%)  3
Inguinal hernia  1  3/2047 (0.15%)  3
Inguinal hernia, obstructive  1  2/2047 (0.10%)  2
Intestinal ischaemia  1  1/2047 (0.05%)  1
Intestinal obstruction  1  4/2047 (0.20%)  4
Intestinal perforation  1  1/2047 (0.05%)  1
Intra-abdominal haemorrhage  1  1/2047 (0.05%)  1
Large intestine perforation  1  1/2047 (0.05%)  1
Lower gastrointestinal haemorrhage  1  4/2047 (0.20%)  4
Melaena  1  6/2047 (0.29%)  6
Nausea  1  2/2047 (0.10%)  3
Oesophageal hypomotility  1  1/2047 (0.05%)  1
Oesophageal spasm  1  1/2047 (0.05%)  1
Oesophageal ulcer  1  1/2047 (0.05%)  1
Pancreatitis  1  3/2047 (0.15%)  3
Pancreatitis acute  1  2/2047 (0.10%)  2
Pancreatitis necrotising  1  1/2047 (0.05%)  1
Peptic ulcer  1  1/2047 (0.05%)  1
Rectal haemorrhage  1  7/2047 (0.34%)  7
Retroperitoneal haematoma  1  1/2047 (0.05%)  1
Retroperitoneal haemorrhage  1  3/2047 (0.15%)  3
Small intestinal haemorrhage  1  3/2047 (0.15%)  3
Small intestinal obstruction  1  8/2047 (0.39%)  8
Swollen tongue  1  1/2047 (0.05%)  1
Toothache  1  1/2047 (0.05%)  1
Umbilical hernia, obstructive  1  1/2047 (0.05%)  1
Upper gastrointestinal haemorrhage  1  6/2047 (0.29%)  7
Volvulus  1  1/2047 (0.05%)  1
Vomiting  1  3/2047 (0.15%)  4
General disorders   
Accidental death  1  1/2047 (0.05%)  1
Asthenia  1  9/2047 (0.44%)  10
Catheter site haematoma  1  1/2047 (0.05%)  1
Catheter site haemorrhage  1  2/2047 (0.10%)  2
Chest discomfort  1  4/2047 (0.20%)  4
Chest pain  1  6/2047 (0.29%)  6
Death  1  9/2047 (0.44%)  9
Device capturing issue  1  1/2047 (0.05%)  1
Device malfunction  1  2/2047 (0.10%)  2
Feeling hot  1  1/2047 (0.05%)  1
Gait disturbance  1  1/2047 (0.05%)  1
General physical health deterioration  1  1/2047 (0.05%)  1
Hernia  1  1/2047 (0.05%)  1
Injection site extravasation  1  1/2047 (0.05%)  1
Injection site haemorrhage  1  1/2047 (0.05%)  1
Malaise  1  1/2047 (0.05%)  1
Multi-organ failure  1  3/2047 (0.15%)  3
Non-cardiac chest pain  1  37/2047 (1.81%)  40
Oedema peripheral  1  2/2047 (0.10%)  2
Pyrexia  1  2/2047 (0.10%)  3
Systemic inflammatory response syndrome  1  1/2047 (0.05%)  1
Thrombosis in device  1  3/2047 (0.15%)  6
Ulcer  1  1/2047 (0.05%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/2047 (0.05%)  1
Cholecystitis acute  1  3/2047 (0.15%)  3
Cholelithiasis  1  3/2047 (0.15%)  3
Gallbladder disorder  1  1/2047 (0.05%)  1
Hepatic cirrhosis  1  1/2047 (0.05%)  1
Hepatic congestion  1  1/2047 (0.05%)  1
Hepatic failure  1  1/2047 (0.05%)  1
Hepatic haemorrhage  1  1/2047 (0.05%)  1
Ischaemic hepatitis  1  1/2047 (0.05%)  1
Jaundice  1  1/2047 (0.05%)  1
Immune system disorders   
Anaphylactic shock  1  1/2047 (0.05%)  1
Antiphospholipid syndrome  1  1/2047 (0.05%)  1
Contrast media allergy  1  3/2047 (0.15%)  3
Drug hypersensitivity  1  1/2047 (0.05%)  1
Food allergy  1  1/2047 (0.05%)  1
Pancreas transplant rejection  1  1/2047 (0.05%)  2
Sarcoidosis  1  1/2047 (0.05%)  1
Infections and infestations   
Abdominal abscess  1  1/2047 (0.05%)  1
Abscess neck  1  1/2047 (0.05%)  1
Appendicitis  1  1/2047 (0.05%)  1
Appendicitis perforated  1  1/2047 (0.05%)  1
Arteritis infective  1  1/2047 (0.05%)  1
Arthritis bacterial  1  2/2047 (0.10%)  2
Bacteraemia  1  6/2047 (0.29%)  6
Bacterial infection  1  1/2047 (0.05%)  1
Bronchitis  1  5/2047 (0.24%)  5
Bronchitis bacterial  1  1/2047 (0.05%)  1
Bursitis infective staphylococcal  1  1/2047 (0.05%)  1
Catheter site infection  1  1/2047 (0.05%)  1
Cellulitis  1  22/2047 (1.07%)  22
Cellulitis staphylococcal  1  1/2047 (0.05%)  1
Clostridium difficile colitis  1  1/2047 (0.05%)  1
Clostridium difficile sepsis  1  1/2047 (0.05%)  1
Cystitis  1  2/2047 (0.10%)  2
Device related infection  1  1/2047 (0.05%)  1
Diverticulitis  1  1/2047 (0.05%)  1
Endocarditis  1  1/2047 (0.05%)  1
Escherichia bacteraemia  1  1/2047 (0.05%)  1
Eye infection staphylococcal  1  1/2047 (0.05%)  1
Gangrene  1  4/2047 (0.20%)  4
Gastroenteritis  1  6/2047 (0.29%)  6
Gastroenteritis Escherichia coli  1  1/2047 (0.05%)  1
Gastroenteritis viral  1  1/2047 (0.05%)  1
Hepatitis B  1  1/2047 (0.05%)  1
Implant site infection  1  1/2047 (0.05%)  1
Incision site infection  1  1/2047 (0.05%)  1
Infected skin ulcer  1  1/2047 (0.05%)  1
Influenza  1  2/2047 (0.10%)  2
Lobar pneumonia  1  5/2047 (0.24%)  6
Localised infection  1  3/2047 (0.15%)  3
Nasopharyngitis  1  1/2047 (0.05%)  1
Osteomyelitis  1  14/2047 (0.68%)  14
Parotitis  1  1/2047 (0.05%)  1
Perineal abscess  1  1/2047 (0.05%)  1
Pharyngitis streptococcal  1  1/2047 (0.05%)  1
Pneumonia  1  47/2047 (2.30%)  52
Pneumonia primary atypical  1  1/2047 (0.05%)  1
Post procedural infection  1  1/2047 (0.05%)  1
Pulmonary sepsis  1  1/2047 (0.05%)  1
Pyelonephritis  1  1/2047 (0.05%)  1
Respiratory syncytial virus infection  1  2/2047 (0.10%)  2
Respiratory tract infection viral  1  1/2047 (0.05%)  1
Rhinovirus infection  1  1/2047 (0.05%)  1
Sepsis  1  11/2047 (0.54%)  12
Septic embolus  1  1/2047 (0.05%)  1
Septic shock  1  7/2047 (0.34%)  7
Staphylococcal abscess  1  1/2047 (0.05%)  1
Staphylococcal infection  1  1/2047 (0.05%)  1
Staphylococcal sepsis  1  2/2047 (0.10%)  2
Streptococcal sepsis  1  2/2047 (0.10%)  3
Tooth abscess  1  1/2047 (0.05%)  1
Urinary tract infection  1  22/2047 (1.07%)  24
Urinary tract infection fungal  1  1/2047 (0.05%)  1
Urosepsis  1  4/2047 (0.20%)  4
Wound abscess  1  1/2047 (0.05%)  1
Wound infection  1  1/2047 (0.05%)  1
Injury, poisoning and procedural complications   
Abdominal wound dehiscence  1  1/2047 (0.05%)  1
Accidental overdose  1  1/2047 (0.05%)  1
Anaemia postoperative  1  2/2047 (0.10%)  2
Ankle fracture  1  3/2047 (0.15%)  3
Arteriovenous fistula site complication  1  1/2047 (0.05%)  1
Arteriovenous fistula site haemorrhage  1  1/2047 (0.05%)  1
Arteriovenous fistula thrombosis  1  2/2047 (0.10%)  2
Cerebral haemorrhage traumatic  1  1/2047 (0.05%)  1
Cervical vertebral fracture  1  1/2047 (0.05%)  1
Complications of transplanted pancreas  1  1/2047 (0.05%)  2
Concussion  1  1/2047 (0.05%)  1
Contrast media reaction  1  1/2047 (0.05%)  1
Dialysis related complication  1  2/2047 (0.10%)  3
Facial bones fracture  1  1/2047 (0.05%)  1
Fall  1  20/2047 (0.98%)  20
Femoral neck fracture  1  2/2047 (0.10%)  3
Femur fracture  1  2/2047 (0.10%)  2
Fibula fracture  1  1/2047 (0.05%)  1
Foot fracture  1  3/2047 (0.15%)  3
Foreign body  1  2/2047 (0.10%)  2
Heat exhaustion  1  1/2047 (0.05%)  1
Hip fracture  1  8/2047 (0.39%)  8
Humerus fracture  1  2/2047 (0.10%)  2
In-stent arterial restenosis  1  2/2047 (0.10%)  2
In-stent coronary artery restenosis  1  2/2047 (0.10%)  3
Injury  1  1/2047 (0.05%)  1
Limb injury  1  1/2047 (0.05%)  1
Lower limb fracture  1  2/2047 (0.10%)  2
Patella fracture  1  1/2047 (0.05%)  1
Pelvic fracture  1  1/2047 (0.05%)  1
Post concussion syndrome  1  1/2047 (0.05%)  1
Post procedural complication  1  1/2047 (0.05%)  1
Post procedural discharge  1  1/2047 (0.05%)  1
Post procedural haematoma  1  3/2047 (0.15%)  3
Post procedural haemorrhage  1  4/2047 (0.20%)  4
Postoperative ileus  1  1/2047 (0.05%)  1
Postoperative wound complication  1  1/2047 (0.05%)  1
Rib fracture  1  1/2047 (0.05%)  1
Spinal compression fracture  1  4/2047 (0.20%)  4
Subdural haematoma  1  2/2047 (0.10%)  2
Thermal burn  1  1/2047 (0.05%)  1
Tibia fracture  1  1/2047 (0.05%)  1
Toxicity to various agents  1  1/2047 (0.05%)  1
Traumatic haematoma  1  1/2047 (0.05%)  1
Traumatic haemorrhage  1  6/2047 (0.29%)  6
Upper limb fracture  1  2/2047 (0.10%)  2
Vascular access complication  1  1/2047 (0.05%)  1
Vascular graft occlusion  1  1/2047 (0.05%)  1
Vascular pseudoaneurysm  1  10/2047 (0.49%)  10
Wound haemorrhage  1  2/2047 (0.10%)  2
Investigations   
Anticoagulation drug level above therapeutic  1  2/2047 (0.10%)  2
Blood creatinine increased  1  1/2047 (0.05%)  1
Blood pressure increased  1  1/2047 (0.05%)  1
Blood urine present  1  3/2047 (0.15%)  3
Cardiac monitoring  1  1/2047 (0.05%)  1
Ejection fraction decreased  1  1/2047 (0.05%)  1
Electrocardiogram QRS complex prolonged  1  1/2047 (0.05%)  1
Hepatic enzyme increased  1  1/2047 (0.05%)  1
Occult blood positive  1  1/2047 (0.05%)  1
Troponin increased  1  4/2047 (0.20%)  4
White blood cell count increased  1  1/2047 (0.05%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/2047 (0.05%)  1
Dehydration  1  3/2047 (0.15%)  3
Diabetes mellitus  1  1/2047 (0.05%)  1
Diabetes mellitus inadequate control  1  1/2047 (0.05%)  1
Diabetic ketoacidosis  1  2/2047 (0.10%)  2
Electrolyte imbalance  1  1/2047 (0.05%)  1
Fluid overload  1  1/2047 (0.05%)  1
Gout  1  1/2047 (0.05%)  1
Hyperammonaemia  1  1/2047 (0.05%)  1
Hyperglycaemia  1  10/2047 (0.49%)  10
Hyperkalaemia  1  10/2047 (0.49%)  10
Hypoglycaemia  1  9/2047 (0.44%)  9
Hypokalaemia  1  3/2047 (0.15%)  3
Hypomagnesaemia  1  1/2047 (0.05%)  1
Hyponatraemia  1  1/2047 (0.05%)  1
Hypovolaemia  1  1/2047 (0.05%)  1
Lactic acidosis  1  3/2047 (0.15%)  3
Metabolic acidosis  1  1/2047 (0.05%)  1
Obesity  1  1/2047 (0.05%)  1
Type 2 diabetes mellitus  1  1/2047 (0.05%)  1
Vitamin B12 deficiency  1  1/2047 (0.05%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/2047 (0.05%)  1
Back pain  1  4/2047 (0.20%)  4
Bursitis  1  2/2047 (0.10%)  2
Cervical spinal stenosis  1  2/2047 (0.10%)  2
Chondrocalcinosis pyrophosphate  1  1/2047 (0.05%)  1
Foot deformity  1  1/2047 (0.05%)  1
Haemarthrosis  1  1/2047 (0.05%)  1
Intervertebral disc degeneration  1  1/2047 (0.05%)  1
Intervertebral disc protrusion  1  1/2047 (0.05%)  1
Joint effusion  1  1/2047 (0.05%)  1
Lumbar spinal stenosis  1  2/2047 (0.10%)  2
Muscular weakness  1  1/2047 (0.05%)  1
Musculoskeletal chest pain  1  3/2047 (0.15%)  3
Musculoskeletal pain  1  2/2047 (0.10%)  3
Neck pain  1  1/2047 (0.05%)  1
Nodal osteoarthritis  1  1/2047 (0.05%)  1
Osteoarthritis  1  10/2047 (0.49%)  10
Pain in extremity  1  2/2047 (0.10%)  2
Rhabdomyolysis  1  4/2047 (0.20%)  4
Rheumatoid arthritis  1  1/2047 (0.05%)  1
Rotator cuff syndrome  1  2/2047 (0.10%)  2
Spinal osteoarthritis  1  1/2047 (0.05%)  1
Spondylolisthesis  1  1/2047 (0.05%)  1
Synovitis  1  1/2047 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1  2/2047 (0.10%)  2
Adenocarcinoma pancreas  1  1/2047 (0.05%)  1
B-cell lymphoma  1  1/2047 (0.05%)  1
Basal cell carcinoma  1  5/2047 (0.24%)  5
Benign gastrointestinal neoplasm  1  2/2047 (0.10%)  2
Bile duct cancer  1  2/2047 (0.10%)  2
Bladder cancer  1  3/2047 (0.15%)  3
Bladder neoplasm  1  1/2047 (0.05%)  1
Breast cancer  1  1/2047 (0.05%)  1
Cardiac myxoma  1  1/2047 (0.05%)  1
Colon adenoma  1  2/2047 (0.10%)  2
Colon cancer  1  5/2047 (0.24%)  5
Colon cancer metastatic  1  1/2047 (0.05%)  1
Diffuse large B-cell lymphoma  1  1/2047 (0.05%)  1
Endometrial cancer  1  1/2047 (0.05%)  2
Gastric cancer  1  1/2047 (0.05%)  1
Hepatic neoplasm malignant  1  2/2047 (0.10%)  3
Laryngeal cancer  1  1/2047 (0.05%)  1
Leukaemia plasmacytic  1  1/2047 (0.05%)  1
Lung adenocarcinoma  1  1/2047 (0.05%)  1
Lung cancer metastatic  1  3/2047 (0.15%)  3
Lung neoplasm  1  3/2047 (0.15%)  3
Lung neoplasm malignant  1  5/2047 (0.24%)  5
Malignant splenic neoplasm  1  1/2047 (0.05%)  1
Mantle cell lymphoma  1  1/2047 (0.05%)  1
Melanoma recurrent  1  1/2047 (0.05%)  1
Metastases to central nervous system  1  1/2047 (0.05%)  1
Metastases to liver  1  1/2047 (0.05%)  1
Metastatic renal cell carcinoma  1  1/2047 (0.05%)  1
Myelodysplastic syndrome  1  2/2047 (0.10%)  2
Oesophageal carcinoma  1  1/2047 (0.05%)  1
Pericardial effusion malignant  1  1/2047 (0.05%)  1
Rectal cancer  1  1/2047 (0.05%)  1
Renal cancer  1  2/2047 (0.10%)  2
Renal cancer metastatic  1  1/2047 (0.05%)  1
Renal cell carcinoma  1  3/2047 (0.15%)  3
Skin cancer  1  1/2047 (0.05%)  1
Skin papilloma  1  1/2047 (0.05%)  1
Small cell lung cancer stage unspecified  1  1/2047 (0.05%)  1
Squamous cell carcinoma  1  1/2047 (0.05%)  1
Thyroid neoplasm  1  1/2047 (0.05%)  1
Nervous system disorders   
Amnesia  1  1/2047 (0.05%)  1
Carotid artery stenosis  1  9/2047 (0.44%)  9
Central nervous system lesion  1  1/2047 (0.05%)  1
Cerebral haemorrhage  1  1/2047 (0.05%)  1
Cerebral infarction  1  3/2047 (0.15%)  3
Cerebrovascular accident  1  40/2047 (1.95%)  42
Cervical cord compression  1  1/2047 (0.05%)  1
Cervicobrachial syndrome  1  1/2047 (0.05%)  1
Convulsion  1  4/2047 (0.20%)  4
Dementia  1  1/2047 (0.05%)  1
Dementia Alzheimer's type  1  1/2047 (0.05%)  1
Depressed level of consciousness  1  1/2047 (0.05%)  1
Diplegia  1  1/2047 (0.05%)  1
Dizziness  1  6/2047 (0.29%)  6
Dysarthria  1  1/2047 (0.05%)  1
Encephalopathy  1  6/2047 (0.29%)  6
Essential tremor  1  1/2047 (0.05%)  1
Frontotemporal dementia  1  1/2047 (0.05%)  1
Guillain-Barre syndrome  1  1/2047 (0.05%)  1
Haemorrhage intracranial  1  1/2047 (0.05%)  1
Hemiparesis  1  1/2047 (0.05%)  1
Hypoaesthesia  1  3/2047 (0.15%)  3
Hypokinesia  1  1/2047 (0.05%)  1
Hypoxic-ischaemic encephalopathy  1  1/2047 (0.05%)  1
Intracranial aneurysm  1  2/2047 (0.10%)  2
Ischaemic cerebral infarction  1  1/2047 (0.05%)  1
Lethargy  1  1/2047 (0.05%)  1
Lumbar radiculopathy  1  1/2047 (0.05%)  1
Metabolic encephalopathy  1  5/2047 (0.24%)  5
Mononeuropathy  1  1/2047 (0.05%)  1
Paraesthesia  1  1/2047 (0.05%)  1
Parkinsonism  1  1/2047 (0.05%)  1
Presyncope  1  5/2047 (0.24%)  5
Radiculopathy  1  1/2047 (0.05%)  1
Sciatica  1  1/2047 (0.05%)  1
Somnolence  1  1/2047 (0.05%)  1
Speech disorder  1  1/2047 (0.05%)  1
Subarachnoid haemorrhage  1  1/2047 (0.05%)  1
Syncope  1  27/2047 (1.32%)  32
Toxic encephalopathy  1  2/2047 (0.10%)  2
Transient ischaemic attack  1  12/2047 (0.59%)  12
Unresponsive to stimuli  1  1/2047 (0.05%)  1
Vascular dementia  1  1/2047 (0.05%)  1
Psychiatric disorders   
Anxiety  1  1/2047 (0.05%)  1
Confusional state  1  1/2047 (0.05%)  1
Delirium  1  2/2047 (0.10%)  2
Depression  1  1/2047 (0.05%)  1
Insomnia  1  1/2047 (0.05%)  1
Mental status changes  1  5/2047 (0.24%)  7
Renal and urinary disorders   
Bladder mass  1  1/2047 (0.05%)  1
Calculus ureteric  1  1/2047 (0.05%)  1
Calculus urethral  1  1/2047 (0.05%)  1
Cystitis haemorrhagic  1  2/2047 (0.10%)  2
Haematuria  1  9/2047 (0.44%)  10
Nephrolithiasis  1  4/2047 (0.20%)  4
Renal artery stenosis  1  3/2047 (0.15%)  3
Renal cyst  1  1/2047 (0.05%)  1
Renal disorder  1  1/2047 (0.05%)  1
Renal failure  1  4/2047 (0.20%)  4
Renal failure acute  1  44/2047 (2.15%)  48
Renal failure chronic  1  10/2047 (0.49%)  10
Renal haemorrhage  1  1/2047 (0.05%)  1
Renal impairment  1  4/2047 (0.20%)  4
Renal mass  1  2/2047 (0.10%)  2
Stress urinary incontinence  1  1/2047 (0.05%)  1
Urethral stenosis  1  1/2047 (0.05%)  1
Urinary bladder haemorrhage  1  1/2047 (0.05%)  1
Urinary incontinence  1  1/2047 (0.05%)  1
Urinary retention  1  2/2047 (0.10%)  2
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/2047 (0.05%)  1
Prostatomegaly  1  1/2047 (0.05%)  1
Testicular swelling  1  1/2047 (0.05%)  1
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  3/2047 (0.15%)  3
Acute respiratory distress syndrome  1  1/2047 (0.05%)  1
Acute respiratory failure  1  34/2047 (1.66%)  38
Aspiration  1  1/2047 (0.05%)  1
Asthma  1  2/2047 (0.10%)  2
Atelectasis  1  2/2047 (0.10%)  3
Chronic obstructive pulmonary disease  1  14/2047 (0.68%)  21
Dyspnoea  1  33/2047 (1.61%)  36
Dyspnoea exertional  1  8/2047 (0.39%)  8
Epistaxis  1  15/2047 (0.73%)  16
Haemoptysis  1  9/2047 (0.44%)  9
Hypoxia  1  4/2047 (0.20%)  4
Pharyngeal haematoma  1  1/2047 (0.05%)  1
Pleural effusion  1  19/2047 (0.93%)  21
Pleuritic pain  1  2/2047 (0.10%)  2
Pneumonia aspiration  1  3/2047 (0.15%)  3
Pneumonitis  1  1/2047 (0.05%)  1
Pneumothorax  1  5/2047 (0.24%)  5
Pulmonary alveolar haemorrhage  1  1/2047 (0.05%)  1
Pulmonary embolism  1  8/2047 (0.39%)  8
Pulmonary fibrosis  1  2/2047 (0.10%)  2
Pulmonary hypertension  1  5/2047 (0.24%)  5
Pulmonary mass  1  1/2047 (0.05%)  1
Pulmonary oedema  1  5/2047 (0.24%)  5
Pulmonary thrombosis  1  1/2047 (0.05%)  1
Respiration abnormal  1  1/2047 (0.05%)  1
Respiratory arrest  1  1/2047 (0.05%)  1
Respiratory distress  1  3/2047 (0.15%)  3
Respiratory failure  1  17/2047 (0.83%)  17
Sinus congestion  1  1/2047 (0.05%)  1
Sleep apnoea syndrome  1  2/2047 (0.10%)  2
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/2047 (0.05%)  1
Diabetic foot  1  1/2047 (0.05%)  1
Drug eruption  1  1/2047 (0.05%)  1
Hyperhidrosis  1  1/2047 (0.05%)  1
Ingrowing nail  1  1/2047 (0.05%)  1
Skin haemorrhage  1  1/2047 (0.05%)  1
Skin ulcer  1  1/2047 (0.05%)  1
Surgical and medical procedures   
Cardiac pacemaker insertion  1  1/2047 (0.05%)  1
Vascular disorders   
Accelerated hypertension  1  1/2047 (0.05%)  1
Aortic aneurysm  1  2/2047 (0.10%)  2
Aortic aneurysm rupture  1  1/2047 (0.05%)  1
Aortic stenosis  1  18/2047 (0.88%)  18
Arteriovenous fistula  1  1/2047 (0.05%)  1
Deep vein thrombosis  1  5/2047 (0.24%)  5
Extremity necrosis  1  1/2047 (0.05%)  1
Femoral arterial stenosis  1  2/2047 (0.10%)  3
Haematoma  1  13/2047 (0.64%)  13
Haemorrhage  1  6/2047 (0.29%)  6
Hypertension  1  12/2047 (0.59%)  12
Hypertensive crisis  1  8/2047 (0.39%)  8
Hypertensive emergency  1  2/2047 (0.10%)  2
Hypotension  1  26/2047 (1.27%)  27
Hypovolaemic shock  1  1/2047 (0.05%)  1
Iliac artery stenosis  1  1/2047 (0.05%)  1
Intermittent claudication  1  6/2047 (0.29%)  7
Jugular vein thrombosis  1  1/2047 (0.05%)  1
Lymphorrhoea  1  1/2047 (0.05%)  1
Malignant hypertension  1  1/2047 (0.05%)  1
Orthostatic hypotension  1  3/2047 (0.15%)  3
Peripheral arterial occlusive disease  1  6/2047 (0.29%)  7
Peripheral ischaemia  1  6/2047 (0.29%)  7
Peripheral vascular disorder  1  2/2047 (0.10%)  3
Reperfusion injury  1  1/2047 (0.05%)  1
Secondary hypertension  1  1/2047 (0.05%)  1
Shock  1  1/2047 (0.05%)  1
Steal syndrome  1  1/2047 (0.05%)  1
Subclavian artery stenosis  1  2/2047 (0.10%)  2
Thrombophlebitis  1  1/2047 (0.05%)  1
Thrombosis  1  2/2047 (0.10%)  2
Venous occlusion  1  1/2047 (0.05%)  1
Venous stenosis  1  1/2047 (0.05%)  1
1
Term from vocabulary, MedDRA 15
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XIENCE
Affected / at Risk (%) # Events
Total   129/2047 (6.30%)    
Cardiac disorders   
Angina pectoris  1  129/2047 (6.30%)  139
1
Term from vocabulary, MedDRA 15
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lijuan Jenn Wang, Advisor, Clinical Affairs
Organization: Abbott
Phone: 01-408-8453133
EMail: Lijuan.wang1@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03218787    
Other Study ID Numbers: 16-308
First Submitted: July 13, 2017
First Posted: July 17, 2017
Results First Submitted: August 25, 2021
Results First Posted: November 5, 2021
Last Update Posted: November 5, 2021